Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363201
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
Sponsor:
Catalysis SL
Organization:
Catalysis SL
Study Overview
Official Title:
Exploratory Study to Evaluate the Effect and Safety of the Use of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exploratory study to evaluate the effect and safety of the use of Ocoxin oral solution on the quality of life of paediatric patients with advanced stage solid tumours
Detailed Description:
This is a prospective open-label single-centre exploratory study in paediatric patients with advanced stage solid tumours receiving oncospecific therapy
Ocoxin The research product registered as a nutritional supplement Ocoxin oral solution manufactured by Catalysis SL of Spain It comes in the form of 30 ml single-dose vials
Forty paediatric patients will be included distributed as follows Hodgkins lymphoma 10 Central Nervous System tumours 10 Sarcoma of any type 10 or Germinal Tumours 10
Patients will receive one vial of Ocoxin daily from the start of oncospecific therapy until two weeks after the end of therapy
Prior to the start of treatment and before each cycle of QT a haemogram and haemochemistry including albumin total proteins transaminases TGO TGP will be performed Physical examinations will be performed and the patients vital signs and body weight will be evaluated
Prior to the start of treatment in month three and four weeks after the end of oncospecific therapy a CT scan will be performed depending on the type of tumour the system for evaluating the efficacy of the oncospecific treatment will be adapted
Quality of life will be assessed using the paediatric quality of life questionnaire PedsQLTm version 40 Spanish The questionnaire will be administered to the parent or guardian prior to the start of treatment at month 3 and at the end of treatment with Ocoxin In the case of longer treatment regimens intermediate quality of life measurements may be taken after the three months and before the end of treatment
The influence of Ocoxin Oral solution on the prevention of admissions due to toxicity attributable to cancer-specific therapy and changes in the patients nutritional status will also be assessed
Safety will be assessed by collecting adverse events AEs analytical parameters physical examinations and vital signs
Effect and safety variables will be summarised using descriptive statistics and frequency counts
Ocoxin The research product registered as a nutritional supplement Ocoxin oral solution manufactured by Catalysis SL of Spain It comes in the form of 30 ml single-dose vials
Forty paediatric patients will be included distributed as follows Hodgkins lymphoma 10 Central Nervous System tumours 10 Sarcoma of any type 10 or Germinal Tumours 10
Patients will receive one vial of Ocoxin daily from the start of oncospecific therapy until two weeks after the end of therapy
Prior to the start of treatment and before each cycle of QT a haemogram and haemochemistry including albumin total proteins transaminases TGO TGP will be performed Physical examinations will be performed and the patients vital signs and body weight will be evaluated
Prior to the start of treatment in month three and four weeks after the end of oncospecific therapy a CT scan will be performed depending on the type of tumour the system for evaluating the efficacy of the oncospecific treatment will be adapted
Quality of life will be assessed using the paediatric quality of life questionnaire PedsQLTm version 40 Spanish The questionnaire will be administered to the parent or guardian prior to the start of treatment at month 3 and at the end of treatment with Ocoxin In the case of longer treatment regimens intermediate quality of life measurements may be taken after the three months and before the end of treatment
The influence of Ocoxin Oral solution on the prevention of admissions due to toxicity attributable to cancer-specific therapy and changes in the patients nutritional status will also be assessed
Safety will be assessed by collecting adverse events AEs analytical parameters physical examinations and vital signs
Effect and safety variables will be summarised using descriptive statistics and frequency counts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None